癌研連線CancerLink
Recruiting NCT06764238

Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol

LeukemiaPhase 2

Building upon the results from the CCCG-ALL-2015, CCCG-ALL-2020 multicenter study cohort, concurrent research findings, and the latest clinical trials, the CCCG-ALL-2025 I/HR-B-ALL is thus developed to further improve the event-free survival (EFS), and overall survival (OS), and quality of life (QoL) of children with intermediate- and high- risk B-cell childhood acute lymphoblastic leukaemia (I/HR-B-ALL), while decreasing adverse reactions and transplantation rates. This trial primarily aims to explore: 1. The efficacy of two randomized Blinatumomab application scheme on I/HR-ALL as determined by MRD negatvitiy rate. 2. The efficacy of modified mini-hyperCVD + Venetoclax in I/HR-ALL cannot afford blinatumomab, in contrast to historical control as determined by MRD negatvitiy rate.

Conditions: Acute Lymphoblastic Leukemia ALL, Childhood Leukemia, Acute Lymphoblastic, B Cell Acute Lymphoblastic Leukemia (B-ALL)

Eligibility Criteria

Inclusion Criteria

  • Age older than 1 month to younger than 18 years.
  • Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
  • Diagnosis of B-ALL by immunophenotyping.

Exclusion Criteria

  • Low-risk ALL
  • sIgM+
  • Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
  • ALL evolved from chronic myeloid leukemia (CML).
  • Down's syndrome, or major congenital or hereditary disease with organ dysfunction
  • Secondary leukemia
  • Known underlying congenital immunodeficiency or metabolic disease
  • Congenital heart disease with cardiac insufficiency.
  • Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.